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目的:通过对多批次样品(包括中药材、中药饮片、中成药、药用辅料)粉碎前后的铬含量检测,证明通过不锈钢材质制药机械进行中药细粉加工将导致产品重金属铬超标。方法:参照《中国药典》2010年版一部附录ⅨB铅、镉、砷、汞、铜测定法,参考《中国药典》2010年版二部明胶空心胶囊“铬”[检查]标准。结果:大部分检验数据显示,样品的铬含量不同程度超标。结论:使用不锈钢材质的制药机械设备会导致中药生产过程中铬超标,给产品质量带来安全隐患。
OBJECTIVE: To test the chromium content before and after crushing many batches of samples (including traditional Chinese medicine, Chinese Herbal Medicine, proprietary Chinese medicines, and medical excipients) to prove that the processing of Chinese traditional medicine powder by stainless steel pharmaceutical machinery will lead to excessive chromium content in the product. Methods: According to the determination of lead, cadmium, arsenic, mercury and copper in an appendix IXB of Chinese Pharmacopoeia 2010 edition, refer to “Chinese Pharmacopoeia” 2010 edition two gelatin hollow capsules “chromium” [check] standards. Results: Most of the test data show that the chromium content of the samples exceeded the standard. Conclusion: The use of stainless steel pharmaceutical machinery and equipment will lead to excessive chromium in the production of traditional Chinese medicine, which will bring potential safety hazard to product quality.